Rx Product News

Kapidex

Indication:
January 30, 2009—The FDA
approved Kapidex (dexlansoprazole) delayed-release
capsules for the once-daily oral treatment of heartburn
associated with symptomatic, nonerosive gastroesophageal
reflux disease, the healing of erosive
esophagitis, and the maintenance of healed erosive
esophagitis. Kapidex is the first proton pump inhibitor
with a dual delayed-release formulation designed to
provide 2 separate releases of medication. The product
decreases acid production by turning off many of
the acid pumps in the stomach, thus helping to protect
the esophagus from acidic reflux so that esophageal
inflammation can heal.

Advair HFA

Marketed by:
Galderma Laboratories LP (Fort Worth, TX)

Indication:
January 8, 2009—GlaxoSmithKline
announced that Advair HFA (fluticasone
propionate and salmeterol
HFA inhalation aerosol), which is an
important treatment for asthma and
is delivered by a metered dose inhaler,
became available with a dose counter. Dose counters
help ensure patients refill their medicine in a timely manner
so they have medication on hand when they need
it?helping them maintain proper asthma management.
Advair is a combination product containing a corticosteroid
and a long-acting beta2-adrenergic agonist indicated
for the maintenance treatment of asthma in patients 4
years of age and older, as well as maintenance treatment
of airflow obstruction and reducing exacerbations
in patients with chron ic obstructive pulmonary disease.

LoSeasonique

Marketed by:
Barr Pharmaceuticals Inc (Montvale, NJ)

Indication:
October 27, 2008—Barr Pharmaceuticals announced
that the FDA approved its subsidiary Duramed
Pharmaceuticals Inc?s new drug application for
LoSeasonique (levonorgestrel/ethinyl estradiol tablets
0.10 mg/0.02 mg and ethinyl estradiol tablets 0.01 mg)
extended-cycle oral contraceptive. LoSeasonique is
the first lower-dose, extended-cycle oral contraceptive
indicated for the prevention of pregnancy. Under the
extended-cycle regimen, women take combination tablets
containing 0.10 mg levonorgestrel/0.02 mg of ethinyl
estradiol daily for 84 straight days, followed by 0.01
mg ethinyl estradiol tablets for 7 days. This regimen is
designed to reduce the number of withdrawal bleeding
periods from 13 to 4 per year.

Premarin Vaginal Cream

Indication:
November 13, 2008—Wyeth Pharmaceuticals
announced that Premarin (conjugated estrogens) Vaginal
Cream 0.5 g was approved for a new indication and a
new less frequent twice-weekly dosing regimen to treat
moderate-to-severe postmenopausal dyspareunia (painful
sexual intercourse; experienced by more than 1 in 4
postmenopausal women). Premarin Vaginal Cream is the
first vaginal estrogen therapy indicated for the treatment
of moderate-to-severe dyspareunia due to menopause.
A low-volume regimen of Premarin Vaginal Cream can
treat painful intercourse due to menopause, restore vaginal
tissue, and reverse changes in the vagina that occur
with menopause.

Ryzolt

Indication:
December 31, 2008—Labopharm announced that
Ryzolt (tramadol HCl extended-release tablets) was
approved by the FDA. Ryzolt is indicated for the management
of moderate to moderately severe chronic
pain in adults who require around-the-clock treatment
of their pain for an extended period of time. It
is a once-daily formulation of the analgesic tramadol.
Ryzolt is a centrally acting analgesic composed of a
dual-matrix delivery system with both immediaterelease
and extended-release characteristics.

Toviaz

Marketed by:
Pfizer Inc (New York, NY)

Indication:
October 31, 2008—Pfizer Inc said that the FDA approved
Toviaz (fesoterodine fumarate) extended-release tablets
for the treatment of overactive bladder (OAB) symptoms.
New once-daily Toviaz can significantly reduce
the number of urge urinary incontinence episodes and
the frequency of urination over 24 hours, symptoms of
OAB that can significantly impact patients? lives. Toviaz
can help regulate the involuntary contractions of the
bladder associated with OAB. These contractions cause
frequent, sudden urges to urinate.

Ranexa

Marketed by:
CV Therapeutics Inc (Palo Alto, CA)

Indication:
November 6, 2008—The FDA approved a new, first-line indication
for Ranexa (ranolazine extended-release tablets) for the treatment of
chronic angina. The new labeling also provides information
showing that Ranexa reduced arrhythmias, including
ventricular arrhythmias, new-onset atrial fibrillation,
and a potentially dangerous slow heartbeat known as
bradycardia in patients with coronary artery disease. The
new labeling also states that Ranexa reduces hemoglobin
A1C in patients with diabetes. Ranexa is indicated
for the treatment of chronic angina and may be used
alone or in combination with traditional therapies, such
as beta-blockers, calcium channel blockers, and nitrates,
and cardioprotective treatments for cardiovascular disease,
such as antiplatelet therapy, lipid-lowering therapy,
angiotensin-converting enzyme inhibitors, and angiotensin
receptor blockers.

Rosaclear System

Marketed by:
Obagi Medical Products Inc (Long Beach, CA)

Indication:
January 20, 2009—Obagi Medical Products announced the launch of the Obagi
Rosaclear System?the first and only complete prescription-based system developed
specifically for treating the signs and symptoms of rosacea. It is designed to reduce
redness and flushing and treat papules and pustules to help rosacea patients achieve
a clearer, calmer, and more balanced-looking complexion. The system includes a
gentle cleanser; Metronidazole Topical Gel USP 0.75%, a prescription medication indicated for the treatment of papules
and pustules associated with rosacea; and a hydrating complexion corrector, which uses calming agents to protect and
moisturize the skin.